Development of Optical Biometer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: New Investigational Optical Biometer (Device), Comparator Device A (Cassini Ambient), omparator Device B (Argos).
- Who it may be relevant to
- Registry conditions: Cataract and IOL Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of a Next-Generation Optical Biometer for Eyes With Cataract
Overview
The Helioscope (Cassini Technologies B.V.) is a novel device under development that aims at combining LED-based corneal topography and SS-OCT to provide accurate and fast measurements of both the corneal shape and the ocular biometry. To that end, the hardware and software of the Cassini color-LED topographer (Cassini Technologies B.V.) is combined with a novel SS-OCT device. While the new Helioscope can largely be evaluated using data acquired with healthy eyes, one of its main use-cases is providing input for IOL power formulae for cataract surgery. Thus, it is essential that the device can perform measurements in eyes with (dense) cataract. As cataract changes the optical properties of the crystalline lens and the OCT measurement is optical, this is not a given. This study therefore seeks a dataset of Helioscope measurements performed in eyes with cataract that can be used to develop the software algorithms of the Helioscope.
Interventions
- Device New Investigational Optical Biometer (Device)
Investigational optical biometer used to obtain axial length, keratometry, anterior chamber depth, lens thickness, and total corneal astigmatism. Device is being evaluated for measurement accuracy and agreement. - Device Comparator Device A (Cassini Ambient)
FDA-cleared corneal topographer used as a reference standard comparator for keratometry. - Device omparator Device B (Argos)
FDA-cleared optical biometer used as a second comparator to assess agreement and measurement differences.
Primary outcome measures
- Ocular parameters of cataractous eyes measured with a novel biometer [Time frame: Overall study to complete up to 12 months]
Secondary outcome measures (1)
- Comparison of ocular biometry measured by a novel biometer against FDA approved devices for planning cataract surgery [Time frame: Overall study to complete up to 12 months]
Eligibility criteria
Inclusion criteria
- The presence of cataract in at least one eye.
- Minimally 21 years of age.
- Provided written informed consent.
Exclusion criteria
- The inability to properly fixate on a fixation target for several seconds
- The inability to provide informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Bishop Eye Center — Hilton Head Island
Publications
- Hashemi H, Sardari S, Yekta A, Khabazkhoob M. The repeatability and agreement of biometric measurements by dual Scheimpflug device with integrated optical biometer. Sci Rep. 2022 May 11;12(1):7748. doi: 10.1038/s41598-022-11953-8. PMID 35546610
Identifiers
NCT: NCT07325162 · 2025-0203